[Federal Register Volume 60, Number 65 (Wednesday, April 5, 1995)]
[Rules and Regulations]
[Pages 17202-17208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8067]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 93N-0283]
RIN 0905-AD89
Food Labeling; Placement of the Nutrition Label on Food Packages
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its food
labeling regulations to provide increased flexibility in the placement
of the nutrition label on packaged foods. In situations in which the
principal display and information panels cannot accommodate all the
required labeling information, and the package has a total surface area
available to bear labeling of greater than 40 square inches (sq in),
the amendment allows the nutrition label to be placed on any panel that
can be readily seen by the consumer. This action is being taken in
response to comments received on the final rule of January 6, 1993,
entitled ``Food Labeling Regulations Implementing the Nutrition
Labeling and Education Act of 1990; Opportunity for Comments,''
(hereinafter ``the implementation final rule''), and on the proposed
rule of August 18, 1993, entitled ``Food Labeling; Placement of the
Nutrition Label on Food Packages.''
EFFECTIVE DATE: May 5, 1995.
FOR FURTHER INFORMATION CONTACT: Arletta M. Beloian, Center for Food
Safety and Applied Nutrition (HFS-165), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5430.
SUPPLEMENTARY INFORMATION:
I. Background
A. The Principal Display Panel and Information Panel
Under FDA's regulations (Sec. 101.1 (21 CFR 101.1)), the part of a
label that is most likely to be displayed, presented, shown, or
examined by a consumer under customary conditions of display for retail
sale is called ``the principal display panel.'' This panel must include
the statement of identity for the product and its net weight. In
addition, to provide consistency and uniformity in the presentation of
label information to consumers, FDA has provided for a second display
panel for information that must be included on the label but that is
not required to appear on the principal display panel. This alternate
panel is called ``the information panel'' (Sec. 101.2 (21 CFR 101.2)).
The information panel is defined in Sec. 101.2(a) as that part of
the label that is immediately contiguous and to the right of the
principal display panel. Section 101.2(a)(1) specifies that if the
first panel to the right of the principal display panel is too small to
accommodate the necessary information, or is otherwise unusable label
space, the panel immediately contiguous and to the right of that part
of the label may be used as the information panel. Accordingly, FDA's
regulations direct manufacturers to move the information required to
appear on the information panel as a unit when the first available
information panel will not accommodate all the required information.
Pursuant to Sec. 101.2(e), all information appearing on the information
panel must be presented in one place without other intervening
material.
Section 101.2(b) states that the ingredient listing; name and place
of business of the manufacturer, packer, or distributor; and nutrition
information must appear either on the principal display panel or on the
information panel, unless otherwise specified by regulation. Section
101.2(d)(1) requires that all information required to appear on the
principal display panel or the information panel appear on the same
panel unless there is insufficient space, in which case it may be
divided between the principal display panel and information panel in
accordance with Secs. 101.1 and 101.2. In determining the sufficiency
of the available space, under Sec. 101.2(d)(1), any vignettes, designs,
and other nonmandatory label information are not to be considered.
B. Mandatory Nutrition Labeling
In the Federal Register of January 6, 1993, FDA issued a final rule
entitled ``Food Labeling: Mandatory Status of Nutrition Labeling and
Nutrient Content Revision, Format for Nutrition Label'' (58 FR 2079)
(hereinafter referred to as ``the mandatory nutrition labeling final
rule''), which included provisions to require nutrition labeling on
most foods that are regulated by FDA and to specify a new format for
declaring nutrition labeling. FDA took this action, in part, to
implement the Nutrition Labeling and [[Page 17203]] Education Act of
1990 (Pub. L. 101-535), which amended the Federal Food, Drug, and
Cosmetic Act. Section 101.9(i) (21 CFR 101.9(i)), which FDA added to
its regulations as part of the mandatory nutrition labeling final rule,
states that, except as provided in Sec. 101.9(j)(13), the location of
the nutrition label must be in accordance with Sec. 101.2.
In recognizing the demands for label space made by nutrition
labeling, the agency included a provision in the mandatory nutrition
labeling final rule that allows nutrition information to be presented
on any label panel on packages that have a total surface area available
to bear labeling of 40 sq in or less (see Sec. 101.9(j)(13)(ii)(D)).
The flexibility provided by this provision reflects the agency's
recognition that it is more important that the nutrition information be
presented on the immediate package than that it be presented in any
particular place (58 FR 2079 at 2156). FDA stated that given the
consistent appearance of the nutrition information that will be
produced by the format elements that it adopted, and the educational
efforts of government, industry, and consumer organizations, consumers
will know to look for, and be able to recognize, nutrition information,
even if it is not presented to the right of the principal display
panel. Section 101.9(j)(13)(ii)(D) does not provide an exception,
however, for the placement of nutrition information on packages of more
than 40 sq in when the principal display and information panels of
those packages cannot accommodate all of the required information.
On January 6, 1993, the agency published, along with the mandatory
nutrition labeling final rule and various other final rules, the
implementation final rule (58 FR 2066). This document gave interested
persons 30 days to comment on any technical issues that had not been
raised in earlier comments. In response to this document, FDA received
a number of comments that requested greater flexibility in the
placement of the nutrition label because of the increased amount of
space needed to meet the type size and spacing requirements of the new
nutrition label. These comments included product labels that
illustrated the difficulties presented in trying to place the required
label information on the information panel.
In the Federal Register of August 18, 1993 (58 FR 44091), FDA
published a proposed rule, entitled ``Food Labeling; Placement of the
Nutrition Label on Food Packages,'' to amend its regulations on the
placement of nutrition information on packages having a total surface
area for labeling of greater than 40 sq in. For such situations, the
agency proposed to add Sec. 101.9(j)(17). Under this provision, when
the package cannot accommodate all information required by regulation
on its principal display panel and information panel, the nutrition
label may be moved to any alternate panel that can be readily seen by
the consumer. Furthermore, under proposed Sec. 101.9(j)(17), the space
needed for vignettes, designs, and other nonmandatory label information
may be considered when determining the sufficiency of available space
on the principal display panel. FDA also proposed to revise: (1)
Sec. 101.9(i) to make reference to the exemption from Sec. 101.2 for
products covered by proposed Sec. 101.9(j)(17), and (2)
Sec. 101.2(d)(1) to exclude from its coverage products that are exempt
under Sec. 101.9(j)(17). FDA also proposed to make a number of
ancillary modifications to all of the regulations that pertain to
relative nutrient content claims, specifically to those sections that
require that the statement that compares the amount of the subject
nutrient in the product per labeled serving with that in the reference
food appear either adjacent to the most prominent claim or on the
information panel. Under the proposed modification, the comparative
quantitative information may be placed either adjacent to the most
prominent claim or to the nutrition label, without regard to the panel
on which the nutrition label appears. The agency proposed to make this
modification to each regulation in part 101 (21 CFR part 101) that
pertains to relative nutrient content claims (e.g., ``more,''
``light'').
In addition, in response to other comments that FDA received on the
implementation final rule, the agency proposed to amend
Sec. 101.61(c)(2)(iii) to require that the statement ``not a sodium
free food'' on foods that are not sodium free and yet whose label bears
a claim of ``unsalted'' be placed adjacent to the nutrition label
rather than on the information panel.
Interested persons were given until October 18, 1993, to comment on
the proposal.
II. Comments and the Agency's Response
FDA received 19 letters, each containing 1 or more comments, in
response to the proposal from trade associations, food manufacturers, a
state government, and a foreign government. The comments unanimously
supported the proposal. However, a few comments contained suggestions
for clarifying the regulations and for modifying additional related
sections that were not covered in the proposal. FDA is responding to
these comments in this document. In addition, the agency received a few
comments that addressed issues such as type size and leading (i.e.,
format) requirements and specific problems pertaining to the placement
of the ingredient list on multi-packs of ready-to-eat cereals. These
issues are outside the scope of the proposal, and therefore FDA will
not address them in this document.
A. Flexibility in Placement
1. All the relevant comments supported FDA's proposal in
Sec. 101.9(j)(17) to allow consideration of the space needed for
vignettes, designs, and other nonmandatory label information on the
principal display panel in deciding whether the space on that panel and
the information panel is adequate for presentation of the nutrition
label. One comment, however, objected to the agency's failure to
provide for consideration of nonmandatory information on the
information panel as part of the determination as to whether there is
sufficient space available for the nutrition label. The comment stated
that the agency's position that the nutrition facts box will be so
recognizable that consumers will not have difficulty locating it
regardless of where it appears on the label seems to support giving
consideration to space needs for vignettes, designs, and other
nonmandatory information on the information panel as well as on the
principal display panel. The comment asked that the agency clarify its
intent and permit nonmandatory label information on the information
panel to be taken into account when deciding whether there is
sufficient space on that panel for the nutrition facts box.
The agency's intent in this rulemaking was not to remove all
constraints on the placement of the nutrition label but rather to
provide added flexibility when needed by industry to facilitate placing
the new nutrition label on food packages. In attempting to accomplish
this purpose, the proposal did not address the issue of nonmandatory
information on the information panel. The agency did not see a need to
alter the current requirement in Sec. 101.2(d)(1) that all required
information (including the nutrition label; the ingredient list; the
name and place of business of the manufacturer, packer, or distributor;
and the percent juice declaration) be placed on the information panel,
if not on the principal display panel, when there is sufficient space
to do so.
In support of the proposal, FDA noted that the appearance of many
packages [[Page 17204]] could be significantly affected if regulations
did not allow vignettes, designs, and other nonmandatory information on
the principal display panel to be considered in calculating the amount
of available label space. The agency also noted that current industry
practice almost never places the nutrition label on the principal
display panel unless there is no alternative panel on the package.
These two factors, which were the impetus for the subject proposal, do
not apply to vignettes, designs, and other nonmandatory information on
the information panel. Thus, the interests of consumers will be served
best by continuing to have this information appear together wherever
possible. Moreover, having the nutrition label, the ingredient list,
and the name and place of business of the manufacturer, packer, or
distributor appear on the same panel simplifies the consumers' search
for this information. The comment did not advance any arguments that
suggested a countervailing benefit to the public from allowing
nonmandatory label information to replace nutrition labeling on the
information panel. Accordingly, the agency is not making the requested
change.
2. One comment stated that the second sentence of proposed
Sec. 101.9(j)(17) needed to be clarified because there was confusion in
trade publications about the significance of nonmandatory information
on the information panel.
FDA agrees that it is necessary to clarify the differences in the
agency's treatment of nonmandatory information on the principal display
panel as opposed to on the information panel. Accordingly, the agency
is revising Sec. 101.9(j)(17) to add a sentence at the end of the
subparagraph that reads: ``Nonmandatory label information on the
information panel shall not be considered in determining the
sufficiency of available space for the placement of the nutrition
label.''
B. Statements of Ingredients, and Name and Place of Business
FDA did not propose to modify the requirement that manufacturers
list ingredient information and the name and place of business of the
manufacturer, packer, or distributor on the principal display panel or
the information panel. Under Sec. 101.9(j)(13) and proposed
Sec. 101.9(j)(17), only the nutrition label could be placed on another
panel.
3. Three comments urged that the agency allow the ingredient
statement (Sec. 101.4) and the name and place of business of the
manufacturer, packer, or distributor (Sec. 101.5) to be presented
adjacent to the nutrition label on any other label panel that can be
readily seen by consumers when the information panel is too small to
accommodate all the required information. They argued that, although
consumers may now look for the ingredient list and the name and place
of business statement on the principal display panel or information
panel, it was likely that these statements would be seen if listed on
the same panel as the nutrition information, which must be readily
observable. Furthermore, the comments argued, consumers are accustomed
to seeing all of this information on one panel, and manufacturers often
incorporate the ingredient list, the name and place of business
statement, and the nutrition label into one design.
Among these comments, one recommended revised wording in
Sec. 101.4(a)(1) to implement the change, i.e., to state that
ingredients are to be listed on either the principal display panel, the
information panel, or the label panel on which the mandatory nutrition
information appears. The comment stated that because Sec. 101.5(a)
requires that the label of a food in package form specify conspicuously
the name and address of the manufacturer, packer, or distributor, that
regulation need not be amended because it allows manufacturers the
option of placing such information in a place where the consumer will
see it.
The agency has considered these comments and is not making the
requested change because a change of the magnitude of that suggested
was not foreshadowed by the proposal. The ingredient statement and the
name and place of business statements have appeared on either the
principal display or the information panels for nearly 20 years.
Allowing the ingredient list and the name and place of business of the
manufacturer, packer, or distributor to move off the information panel
whenever there is insufficient space for them to appear with the
nutrition label would represent a significant redefinition of what
constitutes the information panel. While the portion of the food supply
that would be affected is unknown, it could be substantial. Companies
interested in pursuing this suggestion should submit a citizen petition
under Sec. 10.30 (21 CFR 10.30) that would address the possible
ramifications of such a change on food packages and on consumers' use
of the required label information.
It should be noted, however, that under Sec. 101.2(a)(1), when
there is insufficient space on the panel immediately contiguous and to
the right of the principal display panel for all required components,
the ingredient list; the name and place of business of the
manufacturer, packer, or distributor; and the nutrition label may be
moved as a unit to the next panel immediately contiguous and to the
right of that panel.
C. Clarification
4. One comment requested that FDA allow for the placement of
nutrition information on either side of a center-seamed back panel,
such as on flexible film bags used for snack foods that do not have
information printed on the sides, top, or bottom of the package. The
comment argued that the bag is easily rotated from front to back, and
that the full center-seamed back panel is in plain view.
Section 101.2(a) states that the ``information panel'' is that part
of the label immediately contiguous and to the right of the principal
display panel when observed facing the principal display panel. If the
part of the label immediately contiguous and to the right of the
principal display panel is too small to accommodate the necessary
information, the next panel immediately contiguous and to the right of
the fold may be used (see Sec. 101.2(a)(1)). In the case of flexible
film bags of snack foods with folded or pleated side panels that do not
provide any additional usable label space, the back panel of the bag is
the information panel. FDA interprets the back panel to be the full
back panel of the flexible bag, regardless of the presence or absence
of a seam. Therefore, the nutrition label may be located on any part of
the back panel. Wherever it is placed, however, Sec. 101.2(e) requires
that there be no intervening material between it and the other pieces
of required information.
III. Other Provisions
5. All comments addressing the aspect of the proposal on relative
nutrient content claims supported the proposed requirement that the
comparative quantitative information be positioned adjacent to the most
prominent claim or to the nutrition label. However, in light of
Sec. 101.2(e), which states that all required information on the
information panel appear in one place without other intervening
material, the agency is concerned that the proposed codified language
pertaining to relative claims in Secs. 101.54, 101.56, 101.60, 101.61,
and 101.62 that would require quantitative information to be ``declared
adjacent to the most prominent claim or to the nutrition label * * *''
might be interpreted to mean that when the [[Page 17205]] nutrition
label remains on the information panel, the quantitative information
has to be immediately adjacent to the nutrition label rather than being
allowed to be placed elsewhere on the information panel in proximity
with other required information, as is in fact the case. Such a literal
interpretation of the words ``adjacent to the nutrition label'' could
have the unintended effect of requiring current labels containing
relative claims to be redesigned for the sole purpose of relocating the
quantitative information. The same concern exists for
Sec. 101.61(c)(2)(iii), which addresses the placement of the statement
``not a sodium free food'' on foods that are not sodium free and yet
whose label bears a claim of ``unsalted.''
To prevent such a misunderstanding, FDA is modifying the codified
language pertaining to relative claims (i.e., ``more'' claims:
Sec. 101.54(e)(1)(iii)(B) and (e)(2)(iii)(B); ``light'' claims:
Sec. 101.56(b)(3)(ii), (c)(1)(ii)(B), (c)(2)(ii)(B), and (g); calorie
claims: Sec. 101.60(b)(5)(ii)(B), (b)(6)(ii)(B), (c)(4)(ii)(B), and
(c)(5)(ii)(B); sodium claims: Sec. 101.61(b)(6)(ii)(B) and
(b)(7)(ii)(B); and fat, fatty acid, and cholesterol claims:
Sec. 101.62(b)(4)(ii)(B), (b)(5)(ii)(B), (c)(4)(ii)(B), (c)(5)(ii)(B),
(d)(1)(ii)(F)(2), (d)(2)(iii)(E)(2), (d)(2)(iv)(E)(2), (d)(4)(i)(C)(2),
(d)(4)(ii)(D)(2), (d)(5)(i)(C)(2), and (d)(5)(ii)(D)(2)) and the
general principles governing nutrient content claims in
Sec. 101.13(j)(2)(iv)(B) (21 CFR 101.13(j)(2)(iv)(B)) to state that the
quantitative information ``shall appear adjacent to the most prominent
claim or to the nutrition label, except that if the nutrition label is
on the information panel, the quantitative information may be located
elsewhere on the information panel in accordance with Sec. 101.2.''
(For clarity, FDA is making a small change in the placement of the
illustrative example in these regulations and, for consistency, is
adding an example to Sec. 101.62(d)(4)(i)(C)(2).) Likewise, the agency
is modifying Sec. 101.61(c)(2)(iii), which pertains to the placement of
the statement ``not a low sodium food,'' to state that the statement
shall appear ``adjacent to the nutrition label of the food bearing the
claim, or, if the nutrition label is on the information panel, it may
appear elsewhere on the information panel in accordance with Sec. 101.2
of this chapter.''
IV. Environmental Impact
The agency previously considered the environmental effects of this
rule as announced in the proposed rule of August 18, 1993 (58 FR
44091). No new information or comments have been received that would
affect the agency's previous determination that there is no significant
impact on the human environment and that an environmental impact
statement is not required.
V. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the final
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this final rule will allow for increased
flexibility in complying with labeling rules, and therefore results in
positive net benefits, the agency certifies that the final rule will
not have a significant economic impact on a substantial number of small
entities. Therefore, under the Regulatory Flexibility Act, no further
analysis is required.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
101 is amended as follows:
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act
(5 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342,
343, 348, 371).
2. Section 101.2 is amended by revising paragraph (d)(1) to read as
follows:
Sec. 101.2 Information panel of package form food.
* * * * *
(d)(1) Except as provided by Sec. 101.9(j)(13) and (j)(17), all
information required to appear on the principal display panel or on the
information panel pursuant to this section shall appear on the same
panel unless there is insufficient space. In determining the
sufficiency of the available space, except as provided by
Sec. 101.9(j)(17), any vignettes, designs, and other nonmandatory label
information shall not be considered. If there is insufficient space for
all of this information to appear on a single panel, it may be divided
between these two panels except that the information required pursuant
to any given section or part shall all appear on the same panel. A food
whose label is required to bear the ingredient statement on the
principal display panel may bear all other information specified in
paragraph (b) of this section on the information panel.
* * * * *
3. Section 101.9 is amended by revising paragraph (i) and by adding
new paragraph (j)(17) to read as follows:
Sec. 101.9 Nutrition labeling of food.
* * * * *
(i) Except as provided in paragraphs (j)(13) and (j)(17) of this
section, the location of nutrition information on a label shall be in
compliance with Sec. 101.2.
(j) * * *
(17) Foods in packages that have a total surface area available to
bear labeling greater than 40 square inches but whose principal display
panel and information panel do not provide sufficient space to
accommodate all required information may use any alternate panel that
can be readily seen by consumers for the nutrition label. The space
needed for vignettes, designs, and other nonmandatory label information
on the principal display panel may be considered in determining the
sufficiency of available space on the principal display panel for the
nutrition label. Nonmandatory label information on the information
panel shall not be considered in determining the sufficiency of
available space for the nutrition label.
* * * * *
4. Section 101.13 is amended by revising paragraph (j)(2)(iv)(B) to
read as follows:
Sec. 101.13 Nutrient content claims--general principles.
* * * * *
(j) * * *
(2) * * *
(iv) * * *
(B) This statement shall appear adjacent to the most prominent
claim or to the nutrition label, except that if the nutrition label is
on the information [[Page 17206]] panel, the quantitative information
may be located elsewhere on the information panel in accordance with
Sec. 101.2.
* * * * *
5. Section 101.54 is amended by revising paragraphs (e)(1)(iii)(B)
and (e)(2)(iii)(B) to read as follows:
Sec. 101.54 Nutrient content claims for ``good source,'' ``high,'' and
``more.''
* * * * *
(e) * * *
(1) * * *
(iii) * * *
(B) Quantitative information comparing the level of the nutrient in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``Fiber content of white bread is 1 gram (g) per
serving; (this product) 3.5 g per serving'') is declared adjacent to
the most prominent claim or to the nutrition label, except that if the
nutrition label is on the information panel, the quantitative
information may be located elsewhere on the information panel in
accordance with Sec. 101.2.
(2) * * *
(iii) * * *
(B) Quantitative information comparing the level of the nutrient in
the product per specified weight with that of the reference food that
it replaces (e.g., ``The fiber content of `X brand of product' is 2 g
per 3 oz. This product contains 4.5 g per 3 oz.'') is declared adjacent
to the most prominent claim or to the nutrition label, except that if
the nutrition label is on the information panel, the quantitative
information may be located elsewhere on the information panel in
accordance with Sec. 101.2.
6. Section 101.56 is amended by revising paragraphs (b)(3)(ii),
(c)(1)(ii)(B), (c)(2)(ii)(B), and (g) to read as follows:
Sec. 101.56 Nutrient content claims for ``light'' or ``lite.''
* * * * *
(b) * * *
(3) * * *
(ii) Quantitative information comparing the level of calories and
fat content in the product per labeled serving size with that of the
reference food that it replaces (e.g., ``lite cheesecake--200 calories,
4 grams (g) fat per serving; regular cheesecake--300 calories, 8 g fat
per serving'') is declared adjacent to the most prominent claim or to
the nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located
elsewhere on the information panel in accordance with Sec. 101.2; and
* * * * *
(c) * * *
(1) * * *
(ii) * * *
(B) Quantitative information comparing the level of sodium per
labeled serving size with that of the reference food that it replaces
(e.g., ``lite soy sauce 500 milligrams (mg) sodium per serving; regular
soy sauce 1,000 mg per serving'') is declared adjacent to the most
prominent claim or to the nutrition label, except that if the nutrition
label is on the information panel, the quantitative information may be
located elsewhere on the information panel in accordance with
Sec. 101.2.
(2) * * *
(ii) * * *
(B) Quantitative information comparing the level of sodium per
labeled serving size with that of the reference food that it replaces
(e.g., ``lite canned peas, 175 mg sodium per serving; regular canned
peas 350 mg per serving'') is declared adjacent to the most prominent
claim or to the nutrition label, except that if the nutrition label is
on the information panel, the quantitative information may be located
elsewhere on the information panel in accordance with Sec. 101.2.
* * * * *
(g) The term ``lightly salted'' may be used on a product to which
has been added 50 percent less sodium than is normally added to the
reference food as described in Sec. 101.13(j)(1)(i)(B) and
(j)(1)(ii)(B), provided that if the product is not ``low in sodium'' as
defined in Sec. 101.61(b)(4), the statement ``not a low sodium food,''
shall appear adjacent to the nutrition label of the food bearing the
claim, or, if the nutrition label is on the information panel, it may
appear elsewhere on the information panel in accordance with Sec. 101.2
and the information required to accompany a relative claim shall appear
on the label or labeling as specified in Sec. 101.13(j)(2).
7. Section 101.60 is amended by revising paragraphs (b)(4)(ii)(B),
(b)(5)(ii)(B), (c)(4)(ii)(B), and (c)(5)(ii)(B) to read as follows:
Sec. 101.60 Nutrient content claims for the calorie content of foods.
* * * * *
(b) * * *
(4) * * *
(ii) * * *
(B) Quantitative information comparing the level of the nutrient
per labeled serving size with that of the reference food that it
replaces (e.g., ``Calorie content has been reduced from 150 to 100
calories per serving.'') is declared adjacent to the most prominent
claim or to the nutrition label, except that if the nutrition label is
on the information panel, the quantitative information may be located
elsewhere on the information panel in accordance with Sec. 101.2.
* * * * *
(5) * * *
(ii) * * *
(B) Quantitative information comparing the level of the nutrient in
the product per specified weight with that of the reference food that
it replaces (e.g., ``Calorie content has been reduced from 108 calories
per 3 oz to 83 calories per 3 oz.'') is declared adjacent to the most
prominent claim or to the nutrition label, except that if the nutrition
label is on the information panel, the quantitative information may be
located elsewhere on the information panel in accordance with
Sec. 101.2.
* * * * *
(c) * * *
(4) * * *
(ii) * * *
(B) Quantitative information comparing the level of the sugar in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``Sugar content has been lowered from 8 g to 6 g per
serving.'') is declared adjacent to the most prominent claim or to the
nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located
elsewhere on the information panel in accordance with Sec. 101.2.
(5) * * *
(ii) * * *
(B) Quantitative information comparing the level of the nutrient in
the product per specified weight with that of the reference food that
it replaces (e.g., ``Sugar content has been reduced from 17 g per 3 oz
to 13 g per 3 oz.'') is declared adjacent to the most prominent claim
or to the nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located
elsewhere on the information panel in accordance with Sec. 101.2.
8. Section 101.61 is amended by revising paragraphs (b)(6)(ii)(B),
(b)(7)(ii)(B), and (c)(2)(iii) to read as follows:
Sec. 101.61 Nutrient content claims for the sodium content of foods.
* * * * *
(b) * * *
(6) * * *
(ii) * * *
(B) Quantitative information comparing the level of the sodium in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``Sodium content has been lowered from 300 to 150 mg
per serving.'') is declared adjacent to the most prominent claim or to
the nutrition label, except that if the nutrition label is on the
information [[Page 17207]] panel, the quantitative information may be
located elsewhere on the information panel in accordance with
Sec. 101.2.
* * * * *
(7) * * *
(ii) * * *
(B) Quantitative information comparing the level of sodium in the
product per specified weight with that of the reference food that it
replaces (e.g., ``Sodium content has been reduced from 217 mg per 3 oz
to 150 mg per 3 oz.'') is declared adjacent to the most prominent claim
or to the nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located
elsewhere on the information panel in accordance with Sec. 101.2.
* * * * *
(c) * * *
(2) * * *
(iii) If the food is not sodium free, the statement, ``not a sodium
free food'' or ``not for control of sodium in the diet'' appears
adjacent to the nutrition label of the food bearing the claim, or, if
the nutrition label is on the information panel, it may appear
elsewhere on the information panel in accordance with Sec. 101.2.
* * * * *
9. Section 101.62 is amended by revising paragraphs (b)(4)(ii)(B),
(b)(5)(ii)(B), (c)(4)(ii)(B), (c)(5)(ii)(B), (d)(1)(ii)(F)(2),
(d)(2)(iii)(E)(2), (d)(2)(iv)(E)(2), (d)(4)(i)(C)(2), (d)(4)(ii)(D)(2),
(d)(5)(i)(C)(2), and (d)(5)(ii)(D)(2) to read as follows:
Sec. 101.62 Nutrient content claims for fat, fatty acid, and
cholesterol content of foods.
* * * * *
(b) * * *
(4) * * *
(ii) * * *
(B) Quantitative information comparing the level of fat in the
product per labeled serving with that of the reference food that it
replaces (e.g., ``Fat content has been reduced from 8 g to 4 g per
serving.'') is declared adjacent to the most prominent claim or to the
nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located
elsewhere on the information panel in accordance with Sec. 101.2.
* * * * *
(5) * * *
(ii) * * *
(B) Quantitative information comparing the level of fat in the
product per specified weight with that of the reference food that it
replaces (e.g., ``Fat content has been reduced from 7.5 g per 3 oz to 5
g per 3 oz.'') is declared adjacent to the most prominent claim, to the
nutrition label, or, if the nutrition label is located on the
information panel, it may appear elsewhere on the information panel in
accordance with Sec. 101.2.
* * * * *
(c) * * *
(4) * * *
(ii) * * *
(B) Quantitative information comparing the level of saturated fat
in the product per labeled serving with that of the reference food that
it replaces (e.g., ``Saturated fat reduced from 3 g to 1.5 g per
serving'') is declared adjacent to the most prominent claim or to the
nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located
elsewhere on the information panel in accordance with Sec. 101.2.
* * * * *
(5) * * *
(ii) * * *
(B) Quantitative information comparing the level of saturated fat
in the product per specified weight with that of the reference food
that it replaces (e.g., ``Saturated fat content has been reduced from
2.5 g per 3 oz to 1.7 g per 3 oz.'') is declared adjacent to the most
prominent claim or to the nutrition label, except that if the nutrition
label in on the information panel, the quantitative information may be
located elsewhere on the information panel in accordance with
Sec. 101.2.
* * * * *
(d) * * *
(1) * * *
(ii) * * *
(F) * * *
(2) Quantitative information comparing the level of cholesterol in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``Contains no cholesterol compared with 30 mg
cholesterol in one serving of butter. Contains 13 g of fat per
serving.'') is declared adjacent to the most prominent claim or to the
nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located
elsewhere on the information panel in accordance with Sec. 101.2.
(2) * * *
(iii) * * *
(E) * * *
(2) Quantitative information comparing the level of cholesterol in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``Cholesterol lowered from 30 mg to 5 mg per serving;
contains 13 g of fat per serving.'') is declared adjacent to the most
prominent claim or to the nutrition label, except that if the nutrition
label is on the information panel, the quantitative information may be
located elsewhere on the information panel in accordance with
Sec. 101.2.
(iv) * * *
(E) * * *
(2) Quantitative information comparing the level of cholesterol in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``Cholesterol lowered from 30 mg to 5 mg per serving;
contains 13 g of fat per serving.'') is declared adjacent to the most
prominent claim or to the nutrition label, except that if the nutrition
label is on the information panel, the quantitative information may be
located elsewhere on the information panel in accordance with
Sec. 101.2.
* * * * *
(4) * * *
(i) * * *
(C) * * *
(2) Quantitative information comparing the level of cholesterol in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``[labeled product] 50 mg cholesterol per serving;
[reference product] 30 mg cholesterol per serving'') is declared
adjacent to the most prominent claim or to the nutrition label, except
that if the nutrition label is on the information panel, the
quantitative information may be located elsewhere on the information
panel in accordance with Sec. 101.2.
(ii) * * *
(D) * * *
(2) Quantitative information comparing the level of cholesterol in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``Cholesterol lowered from 55 mg to 30 mg per serving.
Contains 13 g of fat per serving.'') is declared adjacent to the most
prominent claim or to the nutrition label, except that if the nutrition
label is on the information panel, the quantitative information may be
located elsewhere on the information panel in accordance with
Sec. 101.2.
* * * * *
(5) * * *
(i) * * *
(C) * * *
(2) Quantitative information comparing the level of cholesterol in
the product per specified weight with that of the reference food that
it replaces (e.g., ``Cholesterol content has been reduced from 35 mg
per 3 oz to 25 mg per 3 oz.'') is declared adjacent to the most
prominent claim or to the nutrition label, except that if the nutrition
label is on the information panel, the quantitative information may be
located elsewhere on the information panel in accordance with
Sec. 101.2. [[Page 17208]]
(ii) * * *
(D) * * *
(2) Quantitative information comparing the level of cholesterol in
the product per specified weight with that of the reference food that
it replaces (e.g., ``Cholesterol lowered from 30 mg to 22 mg per 3 oz
of product.'') is declared adjacent to the most prominent claim or to
the nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located
elsewhere on the information panel in accordance with Sec. 101.2.
* * * * *
Dated: March 24, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-8067 Filed 3-31-95; 4:32 pm]
BILLING CODE 4160-01-P
